Senior Quality Assurance Analyst

About Hovione

Hovione is an independent family-owned international group of companies with a strong commitment to innovation and excellence. As a leading Contract Development and Manufacturing Company, we help pharmaceutical customers bring new and off-patent drugs to market.

Our diverse team of over 1950 employees from 36 nationalities located across Asia, Europe, and North America work together to achieve our mission. We are dedicated to delivering high-quality products and services that meet the stringent requirements of the pharmaceutical industry.

The Role

We are seeking a highly skilled Senior Quality Assurance Analyst to join our team. This role will be responsible for defining and implementing quality control techniques to verify the quality of raw materials, intermediate, and end products. The successful candidate will also manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.

Duties and Responsibilities

• Defines and implements quality control techniques to verify the quality of raw materials, intermediate, and end products
• Manages and controls all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines
• Rigorously, accurately, efficiently, and professionally manages, executes, and supports all assigned projects in accordance with applicable GMP, quality operational standards/procedures, and legal regulations
• Guides less experienced colleagues in undertaking assigned project tasks
• Proposes new methodologies taking into consideration project demands and requirements
• Executes project-specific analytical tasks and acts as a stakeholder liaison
• Provides an example of professionalism and leads the induction and training of new colleagues within the area
• Ensures that all analytical tasks, including method development, method creation, method transfer, method validation, protocol preparation, and report preparation, in any analytical project are well managed and delivered on time, safely, efficiently, reliably, and in a cost-effective manner
• Solves analytical problems relating to assigned projects by providing collaborative and timely support to all areas and departments, initiating the problem-solving escalation process when unable to solve occurrences within the established period
• Ensures the effective and proactive flow of information between the Analytical team and internal and external (if applicable) stakeholders, establishing relationships and representing the team as appropriate
• Reviews work generated by the team as required, ensuring all procedures are followed
• Creation, investigation, and evaluation of CAPAs, incidents, and deviations
• Performs equipment maintenance, internal calibrations, and internal qualifications on designated laboratory instruments
• Accurately uses and maintains all laboratory information systems
• Maintains good hygiene and housekeeping within the laboratory
• Maintains all laboratory records, project, and general logbooks and notebooks to an acceptable GLP standard and in accordance with Hovione internal procedures
• Fulfils and promotes all applicable GMP requirements and HSE regulations, adhering to all relevant Operating Procedures and industry standards in conducting all analytical activities
• Becomes a leading advocate for safe operating and high-quality performance, alerting ascending colleagues to any potential risks, discrepancies, deviations, or non-conformance in accordance with Hovione internal procedures, suggesting optimizations or improvements
• Proactively assists with audits/investigations as required, following the instruction of QC Management
• Collaborates with management in developing, generating, and proactive reporting of KPIs for the team
• Maintains advanced analytical chemistry expertise, sharing knowledge of new technologies and methodologies within the area
• Leads relevant training delivery to other areas in accordance with support development of training plans by recommending training needs
• Leads the induction and training of new colleagues
• Drives high standards in the QC Laboratories
• Uses, and supports others on the use of, analytical techniques and instrumentation, such as gas and high-performance liquid chromatography (HPLC) amongst others
• Interprets data and analysis to ensure meeting strict guidelines on documentation and recording data
• Works collaboratively in cross-functional teams and understands each department's function and role in delivery of tests and products
• Masters quality control processes and tools
• Manages complex projects/analysis with significant impact on business
• Makes quality and timely decisions based on multiple sources of data
• Manages risk and uncertainty; anticipates and escalates roadblocks in order to prevent deviations to the goals
• Carries out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations, and codes of practice
• Executes professional activities in compliance with GMP and HSE guidelines, internal and external requirements, as well as promotes the implementation and maintenance of Hovione's policies, systems, and procedures (COPs, HBR, SOPs, and others)
• Undertakes any additional tasks commensurate with the role as and when required

Requirements and Qualifications

We are looking for a highly skilled and experienced Senior Quality Assurance Analyst who has:

• Mastery's degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or similar fields
• Typically requires 5-8 years of relevant experience in a pharmaceutical QC laboratory environment
• Strong hands-on experience in Analytical Chemistry, Development, and Validation of analytical methods and QC procedures
• Advanced training and experience of GMP and ICH guidelines standards
• Good working knowledge on HPLC and GC, and familiarity with Empower Software
• Advanced knowledge of GMP practices, analytical theory, and techniques with the ability to solve complex problems
• Fluency in English is a requirement
• Computer literate with good working knowledge of the MS Office package
• Must have the knowledge, experience, and skills to conduct their tasks in accordance with the rules and procedures set down
• Strong documentation skills and attention to detail

Salary Range

This role comes with a salary range of $80,000 - $110,000 per year, depending on experience and qualifications.

Benefits

Hovione offers a competitive benefits package, including:

• Health insurance
• Dental insurance
• Vision insurance
• 401(k) plan
• Stock options
• Flexible working hours
• Paid vacation time
• Paid sick leave
• Professional development opportunities

Location

This role is based at one of our production sites in the US, Portugal, Macao, Ireland, China, Hong Kong, Japan, India, or Switzerland.